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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.

Symptomatic skeletal event free survival (SSE-FS).; From time of randomization up to 25 months

Secondary Outcome Measures

Overall survival; From time of randomization up to 25 months; Time to opiate use for cancer pain; From time of randomization up to 25 months; Time to pain progression (only in subjects with baseline worst pain score ≤8); From time of randomization up to 25 months; Time to cytotoxic chemotherapy; From time of randomization up to 25 months; Radiological progression-free survival (rPFS); From time of randomization up to 25 months; Frequency of abnormalities in laboratory examinations.; From time of randomization up to 25 months; Pain Improvement Rate; From time of randomization up to 25 months; To measure new primary malignancies and hematopoietic reserve for tolerability of subsequent chemotherapy; From time of randomization up to 25 months

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.

Gender

Female

Age Range

18 Years - N/A

Who Can Participate

Patients

Number of Participants

227

Participant Inclusion Criteria

Inclusion Criteria: - Documentation of histological or cytological confirmation of estrogen receptor
positive (ER+) and HER2 negative adenocarcinoma of the breast must be available. - Women (≥18 years of age) with metastatic breast cancer not amenable to curative
treatment by surgery or radiotherapy. - Documentation of menopausal status: post menopausal or premenopausal subjects are
eligible. - Subjects with bone dominant disease with at least 2 skeletal metastases identified at
baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI).
Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph
nodes)and/or visceral metastases is allowed. - Measurable or non-measurable disease (but radiologically evaluable) according to
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. - Subjects must have received at least one line of hormonal therapy in the metastatic
setting - Subjects who are eligible for further standard of care endocrine treatment. - Subjects enrolled in the current study must start treatment with the single hormone
agent either within 15 days prior to randomization or after randomization (before or
simultaneously to the first injection of Ra-223/placebo). - Subjects must have experienced no more than two skeletal-related events (SREs) prior
to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone,
pathological bone fracture (excluding major trauma), spinal cord compression and/or
orthopedic surgical procedure. Subjects with no prior SREs are not permitted. - Subjects must be on therapy with bisphosphonate and denosumab. and are required to
have been on such therapy for at least 1 month before start of study treatment. - Adequate hematological, liver and kidney function. Exclusion Criteria: - Subjects with Inflammatory breast cancer. - Subjects who have either received chemotherapy for metastatic disease or are
considered by the treating investigator to be appropriate candidates for chemotherapy
as current treatment for metastatic breast cancer are excluded. Chemotherapy
administered for adjuvant/neo adjuvant disease is acceptable. - Subjects with known or history of brain metastases or leptomeningeal disease: subjects
with neurological symptoms must undergo a contrast CT scan or MRI of the brain within
28 days prior to randomization to exclude active brain metastasis. Imaging of the
central nervous system (CNS) is otherwise not required. - Known presence of osteonecrosis of jaw. - Patients with immediately life-threatening visceral disease, for whom chemotherapy is
the preferred treatment option. - Lymphangitic carcinomatosis. - Patients with ascites requiring paracentesis within 2 weeks prior to study entry
(signature of informed consent) and during the screening period.

Participant Exclusion Criteria

This is in the inclusion criteria above

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.

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